The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Mycoplasma Slurry And Mycoplasma Crowntitre Ifa Test System.
| Device ID | K946373 |
| 510k Number | K946373 |
| Device Name: | MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM |
| Classification | Antisera, Fluorescent, All, Mycoplasma Spp. |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | GRZ |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1996-02-07 |